Back to resultsNOVOCART 3D Treatment Following Microfracture Failure
Primary Purpose
Articular Cartilage Defect
Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
NOVOCART 3D
Sponsored by
About this trial
This is an interventional treatment trial for Articular Cartilage Defect focused on measuring cartilage repair, cartilage regeneration, cartilage reconstruction, cartilage restoration, autologous chondrocyte implantation, matrix associated chondrocyte implantation
Eligibility Criteria
Inclusion Criteria:
- participated in study AAG-G-H-1220
- identified as a microfracture failure patient
- voluntary consent to participate in the study
Exclusion Criteria:
- other cartilage repair procedures performed on target knee
- other conditions that would interfere with healing or evaluating outcomes
- lesions requiring implants larger than 9cm2
- non-compliance with requirements in study AAG-G-H-1220
Sites / Locations
- Ohio State UniversityRecruiting
- Alpine OrthopaedicsRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
NOVOCART 3D
Arm Description
Matrix associated autologous chondrocyte implant
Outcomes
Primary Outcome Measures
KOOS pain subdomain score
Comparison of pain scores from the KOOS questionnaire from baseline
Secondary Outcome Measures
KOOS function subdomain score
Comparison of function scores from the KOOS questionnaire from baseline
VAS pain scale
Comparison of pain from baseline
IKDC subjective scores
Comparison of IKDC subjective scores from baseline
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03219307
Brief Title
NOVOCART 3D Treatment Following Microfracture Failure
Official Title
Safety and Efficacy of NOVOCART 3D in the Treatment of Articular Cartilage Defects Following Failure on Microfracture
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 30, 2018 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aesculap Biologics, LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is prospective single arm extension study of protocol AAG-G-H-1220. It is open only to participants of AAG-G-H-1220 randomized to the Microfracture treatment group.
Detailed Description
This study is an extension of protocol AAG-G-H-1220 wherein patients were randomized to either NOVOCART 3D or Microfracture treatment groups. This prospective single arm extension study is only open to participants of AAG-G-H-1220 who were randomized to Microfracture treatment and who failed Microfracture treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Articular Cartilage Defect
Keywords
cartilage repair, cartilage regeneration, cartilage reconstruction, cartilage restoration, autologous chondrocyte implantation, matrix associated chondrocyte implantation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
NOVOCART 3D
Arm Type
Experimental
Arm Description
Matrix associated autologous chondrocyte implant
Intervention Type
Combination Product
Intervention Name(s)
NOVOCART 3D
Intervention Description
Matrix associated autologous chondrocyte implant
Primary Outcome Measure Information:
Title
KOOS pain subdomain score
Description
Comparison of pain scores from the KOOS questionnaire from baseline
Time Frame
24 months
Secondary Outcome Measure Information:
Title
KOOS function subdomain score
Description
Comparison of function scores from the KOOS questionnaire from baseline
Time Frame
24 months
Title
VAS pain scale
Description
Comparison of pain from baseline
Time Frame
24 months
Title
IKDC subjective scores
Description
Comparison of IKDC subjective scores from baseline
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
66 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
participated in study AAG-G-H-1220
identified as a microfracture failure patient
voluntary consent to participate in the study
Exclusion Criteria:
other cartilage repair procedures performed on target knee
other conditions that would interfere with healing or evaluating outcomes
lesions requiring implants larger than 9cm2
non-compliance with requirements in study AAG-G-H-1220
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Sisler, BSN, RN
Phone
610-984-4218
Email
jennifer.sisler@aesculapbiologics.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Collins
Phone
310-948-8400
Email
sarah.collins@aesculapbiologics.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Spiro, PhD
Organizational Affiliation
Aesculap Biologics
Official's Role
Study Director
Facility Information:
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Courtney Wright
Phone
614-293-2410
First Name & Middle Initial & Last Name & Degree
David Flanigan, MD
Facility Name
Alpine Orthopaedics
City
North Logan
State/Province
Utah
ZIP/Postal Code
84341
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
435-774-8512
First Name & Middle Initial & Last Name & Degree
Brad Larson, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.clinicaltrials.gov/ct2/show/NCT01957722?term=novocart+3d&rank=1
Description
Main Clinical Study AAG-G-H-1220
Learn more about this trial
NOVOCART 3D Treatment Following Microfracture Failure
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